The Mochudi Prevention Project ART Protocol

This study has been terminated.
(Low Accrual.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Max Essex, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT01583439
First received: April 11, 2012
Last updated: May 17, 2013
Last verified: May 2013

April 11, 2012
May 17, 2013
September 2012
February 2013   (final data collection date for primary outcome measure)
  • The proportion of individuals with CD4≥250 cells/mm3 and VL≥50,000 cp/mL who start 3-drug ART [ Designated as safety issue: No ]
  • The proportion of patients experiencing Grade 3 or 4 clinical or laboratory adverse events by the end of follow-up [ Designated as safety issue: Yes ]
  • The proportion of participants with excellent adherence (defined as participant self-report of taking at least 95% of doses of antiretrovirals during the previous 4 days, on all assessments) by the end of follow-up [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01583439 on ClinicalTrials.gov Archive Site
  • Presence of ARV drug resistance at time of virologic failure on first- and second-line treatment, among participants experiencing virologic failure [ Designated as safety issue: Yes ]
  • Time to first opportunistic infections [ Designated as safety issue: Yes ]
  • Time to death [ Designated as safety issue: Yes ]
  • Time to first episode of non-adherence: the first episode of non-adherence will be the report of the failure of a patient to take 95% of prescribed pills, or participant self-discontinuation of antiretrovirals. [ Designated as safety issue: No ]
  • Motivation for / barriers to acceptance of ART will be analyzed descriptively [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Mochudi Prevention Project ART Protocol
An Evaluation of the Uptake and Safety of, and Adherence to Antiretroviral Treatment Among Individuals With CD4 ≥ 250 Cells/mm3 and HIV Virus Load ≥ 50,000 cp/mL

The goal of the "Mochudi Prevention Project" is to reduce the number of new HIV infections in the village of Mochudi, Botswana by promoting a comprehensive package of interventions that have proven to be effective in preventing the spread of HIV. This antiretroviral treatment (ART) clinical study is nested within the Mochudi Prevention Project, and is being conducted in the north-east segment (NES) of the village of Mochudi. The ART intervention component of the Mochudi Project is designed to determine the uptake of, adherence to, and feasibility of 3-drug combination ART as a component of a package of transmission prevention strategies. The hypotheses are 1) that ART (with 3 antiretrovirals from two classes of drugs) among participants with CD4 ≥ 250 cells/mm3 and VL ≥ 50,000 cp/mL will be acceptable and safe and 2) Eighty percent of eligible participants will agree to start 3-drug ART.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
Drug: highly active antiretroviral therapy: Lopinavir/Ritonavir, Lamivudine, Zidovudine, Efavirenz, Tenofovir Disoproxil Fumarate, Emtricitabine
Atripla: one tablet administered orally once daily at bedtime, each tablet comprised of co-formulated: Efavirenz (EFV) 600mg, Emtricitabine (FTC) 200mg, Tenofovir disoproxil fumarate (TDF) 300mg(EFV/FTC/TDF). Note: the study will generally provide the fixed-dose combination Atripla, but it will also be permissible for the same drugs to be used at the same doses as individual components (or as Truvada, coformulated TDF/FTC). Other drug substitutions may be made per the protocol.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
September 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-1 infection
  • CD4 cell count ≥ 250 cells/mm3
  • HIV-1 RNA ≥ 50,000 cp/mL
  • No AIDS-defining illness or other illness that would cause volunteer to be eligible for ART through the Botswana National Program (these volunteers should be referred to the National Program for treatment)
  • Age 16 to 64 years
  • Botswana citizen
  • Resident of the north-east segment of Mochudi
  • The following laboratory values obtained within 60 days prior to study enrollment:

    • Absolute neutrophil count (ANC) ≥ 500 cells/mm3.
    • Hemoglobin ≥ 7.0 g/dL.
    • AST (SGOT), ALT (SGPT), and bilirubin ≤ 5 X ULN. Note: if the estimated creatinine clearance (by Cockgroft-Gault equation) is <60 mL/min, then TDF/FTC will be substituted with ZDV/3TC
  • Ability to swallow oral medications.
  • Ability and willingness of participant to give informed consent (or in case of participants < 18 years of age, ability and willingness to provide assent; and for parent/guardian to provide consent).
  • Not currently involuntarily incarcerated.
  • Karnofsky performance score ≥ 70 at time of study enrollment.
  • If participating in sexual activity that could lead to pregnancy and of reproductive potential, female participants must use two reliable methods of contraception simultaneously, one of which must be a barrier method, while receiving protocol-specified medications, and for 12 weeks after stopping the medications.
  • For participants < 18 years of age: Weight of 40kg or more

Exclusion Criteria:

  • Receipt at any time prior to study enrollment of > 7 days cumulative treatment with any ARV or combination of ARVs (except ARVs taken for any length of time during pregnancy for the prevention of mother-to-child transmission (pMTCT) or ARVs taken for occupational exposure).
  • Current receipt of 3-drug ART for pMTCT
  • Allergy/sensitivity to any study drug or its formulations.
  • Acute therapy for serious medical illnesses, in the opinion of the site investigator, within 14 days prior to enrollment.
Both
16 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Botswana
 
NCT01583439
BHP041, R01AI083036
Yes
Max Essex, Harvard School of Public Health
Harvard School of Public Health
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Max Essex, DVM, PhD Harvard School of Public Health
Principal Investigator: Victor DeGruttola, S.M., Sc.D. Harvard School of Public Health
Harvard School of Public Health
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP